3D Printers Used to Manufacture Medical Parts Should be Regulated

As a company that has been inventing and manufacturing 3D printers and materials for 15 years, our company has had a front-row seat to amazing changes in the way things are made. We are also confident that much more progress is on the horizon, especially when it comes to medical applications.

While the benefits to consumers, businesses and the economy as a result of 3D printing can be profound, so, too, is the painful disruption.

Unfortunately, a great deal of that disruption is happening to manufacturers themselves. Increasingly, they find themselves cut out of the equation as 3D printers enable the process of making things to move closer and closer to the end user and, in many cases, take manufacturing of certain objects out of actual manufacturing facilities altogether. In many cases, 3D printing is also reducing demand for traditional processes, putting a squeeze on, say, cutting-tool makers.

Take the dental industry. Dentists and orthodontists are buying 3D printers to manufacture objects that were once made nearly exclusively by dental laboratories and manufacturers. Today, these doctors can 3D print a custom device without any involvement of a lab or manufacturer.

Vida cDLM dental 3D printer

While some of those labs and manufacturers are figuring out ways to adapt to these changes with their own new approaches to 3D printing services, it’s still a painful period for many companies. They must contend with lower demand for their services or reinvent their business models.

At the same time, this shift to more local manufacturing also raises serious safety and regulatory issues. Should an orthodontist office with a 3D printer now face the same kind of regulatory review as a laboratory or manufacturer to protect part quality and patients? Do all 3D printers really offer the same level of quality as a laboratory or manufacturer? Or, should the regulation fall on the printer and materials themselves?

These are serious questions whose answers will directly impact patient safety. In fact, we believe the existing lack of rules in key areas is already creating potential problems in the marketplace. At EnvisionTEC we routinely see 3D printers being advertised to clinicians that cannot deliver the accuracy they promise or that is required for some applications.

In May 2016, the FDA issued “Technical Considerations for Additive Manufactured Devices” to solicit guidance on these types of issues. In August, AdvaMed, the association for medical device manufacturers, encouraged the FDA, in the interest of patient safety, to consider adding a statement “that a point-of-care establishment that installs 3D printers and uses those 3D printers to routinely manufacture devices … are subject to relevant FDA requirements, including premarket review if applicable, and post-market controls such as establishing and maintaining quality systems and adverse event reporting.”

Johnson & Johnson raised similar objections, saying “the installation of 3D printers and the routine manufacturing of devices using additive manufacturing techniques in hospitals, physician offices, finishing laboratories and similar establishments exceed the limits” of an exemption that had been set for “licensed practitioners, including physicians, dentists and optometrists, who manufacture or otherwise alter devices solely for use in their practice.”

Al Siblani, EnvisionTEC CEO.

While we recognise medical device manufacturers want to protect patients, and also themselves from the threat of manufacturing directly at the point of clinical service, EnvisionTEC does not want to see progress staunched by unnecessary regulation. We believe the recommendation by AdvaMed places too high a burden on clinicians and compromises the time and cost progress that 3D printers offer clinicians and patients.

That said, we do recognise that the market for 3D printers for clinicians has become a bit like the Wild West. As a result, we at EnvisionTEC welcome direct regulation of 3D printers and materials to protect both consumers and clinicians, who may be convinced to buy products that simply cannot meet clinical needs that laboratories and manufacturers have strived so diligently to meet for years.

As manufacturers of the 3D-Bioplotter and desktop and production printers that make in-ear, in-mouth and other medical devices for use in and outside of the body, we are registered with the FDA and take quality seriously.

So, yes, this recommendation is an extra burden for 3D printer companies such as ourselves, but it’s one we increasingly believe is necessary and responsible.

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Comments (2)

3D Printers Used to Manufacture Medical Parts Should be Regulated

You stated "We believe the recommendation by AdvaMed places too high a burden on clinicians and compromises the time and cost progress that 3D printers offer clinicians and patients". Lots of things cause burden in the use of a produce, I have to put gas in my car and/or charge my battery if I want to drive a car and is a burden, but it is required.So, WHY do you feel that a part manufactured inside a dental office should not have the same regulations and quality processes as ones manufactured outside the office at a lab or factory? Yes, it does cause extra burden - but I don't see why a dental office would not have to follow FDA QSR rules just like every other manufacturer of the part when it is manufactured off-site. What it really sounds like you are saying is "Geez, that takes away some of the benefit of 3D printing in the office" and which is a profit motivation way to .look at this issue versus the safety of the patients involved. Note: I have no horse in this race and am not involved in 3D printing or any dental product that creates/manufactures these appliances and devices - but I am involved in Dental Imaging and embrace the QSR and FDA regulations to keep patients SAFE.

Dougmore than 2 years ago

Protectionist

Al Siblani: You sound like a corporate shill protecting his business interests through regulation. Maybe you should change your business model to reflect the inevitable market shift that will happen with or without you.